510(k) K192109 ยท LLZ System, Image Processing, Radiological
KOALA
| Applicant | Ib Lab GmbH, Vienna, AT |
| Decision | Substantially Equivalent, Nov 5, 2019 |
| Received | Aug 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192109
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.